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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00072605 |
This study will test the safety of an experimental vaccine developed to protect against Ebola virus infection and to determine if the vaccine induces an immune response to the virus. The Ebola virus causes a disease called Ebola hemorrhagic fever. Symptoms begin with fever and muscle aches and progress to breathing problems, severe bleeding, kidney problems, and shock. The infection may be mild, but it can also lead to death. The vaccine used in this study is made from small parts of Ebola genetic material. It cannot cause Ebola hemorrhagic fever to develop in those who receive it.
Healthy volunteers 18 to 44 years of age may be eligible for this study. Candidates will be screened with a medical history, physical examination, and laboratory tests, and complete an "assessment of understanding" questionnaire to show that they understand the study.
Depending on their order of entry into the study, participants are assigned to receive one of three vaccine doses or placebo. The first group receives the lowest dose (2 milligram) of vaccine or placebo. If this dose is safe, then the second group receives 4 mg, and if this dose is safe, the third group receives 8 mg. Injections are given in a muscle in the upper arm. Participants receive three injections, each 4 weeks apart (on study days 0, 28, and 56).
Participants record their temperature and symptoms in a diary card for 7 days following each injection. They return to the clinic 2 to 3 days after each injection and then 2 weeks after each injection until study week 10. Additional follow-up visits are then scheduled at weeks 12, 24, 38, and 52. At each visit, participants provide a blood and urine sample for testing and have their vital signs, and lymph nodes checked, their weight measured, and their symptoms reviewed. Additional laboratory tests may be requested between visits.
Condition | Intervention | Phase |
---|---|---|
Hemorrhagic Fever, Ebola Healthy |
Drug: VRC-EBODNA012-00-VP |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of a Multiple Strain Ebola DNA Plasmid Vaccine, VRC-EBODNA012-00-VP, in Adult Volunteers |
Estimated Enrollment: | 27 |
Study Start Date: | October 2003 |
Estimated Study Completion Date: | August 2007 |
This is a Phase I, randomized, placebo-controlled, dose-escalation study of an Ebola DNA plasmid vaccine. The hypothesis is that the vaccine will be safe for human administration and elicit immune responses to Ebola. Primary objectives are to evaluate the safety and tolerability of the investigational vaccine and the secondary objective is to evaluate immune responses. Randomization assignment will be blinded to subjects, clinical investigators and laboratory investigators.
Ages Eligible for Study: | 18 Years to 44 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
A volunteer must meet all of the following inclusion criteria:
Physical examination and laboratory results without clinically significant findings within the 28 days prior to enrollment.
Laboratory Criteria within 28 days prior to enrollment:
Normal urinalysis defined as negative glucose, negative or trace protein, and negative hemoglobin by dipstick.
Female-Specific Criteria:
No reproductive potential because of menopause (one year without menses) or because of a hysterectomy, bilateral oophorectomy, or tubal ligation,
or
Participant agrees to be heterosexually inactive at least 21 days prior to enrollment and throughout the duration of the study,
or
Participant agrees to consistently practice contraception at least 21 days prior to enrollment and throughout the duration of the study by one of the following methods:
EXCLUSION CRITERIA:
A volunteer will be excluded if one or more of the following conditions apply.
Women:
Breast-feeding.
Volunteer has received any of the following substances:
Current anti-TB prophylaxis or therapy.
Volunteer has a history of any of the following clinically significant conditions:
Study ID Numbers: | 040028, 04-I-0028 |
Study First Received: | November 4, 2003 |
Last Updated: | August 23, 2007 |
ClinicalTrials.gov Identifier: | NCT00072605 |
Health Authority: | United States: Federal Government |
Healthy T Cells Immunity |
Hemorrhagic Fever Healthy Volunteer HV |
Virus Diseases Fever Hemorrhagic Fevers, Viral Hemorrhagic Fever, Ebola |
Hemorrhagic fever Viral hemorrhagic fever Healthy |
RNA Virus Infections Filoviridae Infections Mononegavirales Infections |